Quality Analyst-00000TJZ
Description
Essential duties and Responsibilities
(Which are the main and critical duties of your job and its results. While addressing each responsibility, think about the fact of: “Doing something to achieve certain results)
1. Responsible for the Supplier program. It includes, perform Quality audits to them in order to approve/reject them, report findings, maintain the Approved Supplier List updated, as well as, the supporting documentation; and ensure the entire organization follow the established process for Suppliers.
2. Responsible for the Distributor Program. It includes, perform Quality audits to new and legacy distributors in order to approve/reject them, report findings, support the development of distributors, since the Quality Stand point, maintain Approved Distribution List updated; as well as, their supporting documentation; lead effort to improve the system in the region.
3. Perform Quality audits to the operation and facilities of MDD Distributors across LATAM Region according to the Audit Program.
4. Provide audit reports by written of all Quality Audits conducted and provide follow-up to the audits, as needed
5. Analyze results obtained during the audits, build and keep an updated dashboard for Suppliers, Distributors, Servicios Integrales and In Plants
6. Lead the Distributor Program in Mexico, and if needed in the Region
7. Implement the Quality Management System (QMS) in all sites with a business model of “In Plants” or “Servicios Integrales”, ensuring the operations meet the Good Warehousing and Distribution Practices according to the Local Regulation
8. Ensure full implementation of the QMS in the sites and/or areas assigned to his/her responsibility
9. Provide training on Quality Systems and/or any related topic, as needed.
10. Report to the Quality and Compliance Manager, as well as, CLS Manager any activity that may present risks within the J&J operation or within an In Plant or Servicios Integrales facility
11. Ensure products are stored and handled according to the regulatory requirements, and J&J policies dealing with Quality, Health & Safety and Environmental in all In Plant and Servicios Integrales locations
12. Has authority to stop any process that is a high potential risk for quality product or regulatory aspect.
13. Receive any Inspection / Visit from the Heath Authority in an In Plant
14. Became a back-up in any other System such as Product Complaints, Compliance Alert, CoAs, Training, Change Control, CAPAs, etc; as needed.
15. Support any other Quality System implementation, as needed.
Qualifications
Education
Experience
- Bachelor of Science Graduated on: Chemistry, Biochemistry, Biology, Engineer or any other similar Bs in the medical-biological field
- English: 80%
- Full command in communication, writing and oral.
- At least 3 to 5 years of experience implementing Quality Systems
- Experience conducting Quality Audits
- Experience in CAPAs, Change Control, Validation, Cold chain, training, data analysis, project administration and SOPs preparation.
- Knowledge in Local Regulation, such as, NOM 240 and NOM 241.
- Full command in Microsoft Office (Excel, Word, PP).
- Desirable: Experience in Medical Devices, Post Market Surveillance (Technovigilance) and Complaint Handling.
Primary Location:Latin America-Mexico
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Quality (Eng)
Description
Essential duties and Responsibilities
(Which are the main and critical duties of your job and its results. While addressing each responsibility, think about the fact of: “Doing something to achieve certain results)
1. Responsible for the Supplier program. It includes, perform Quality audits to them in order to approve/reject them, report findings, maintain the Approved Supplier List updated, as well as, the supporting documentation; and ensure the entire organization follow the established process for Suppliers.
2. Responsible for the Distributor Program. It includes, perform Quality audits to new and legacy distributors in order to approve/reject them, report findings, support the development of distributors, since the Quality Stand point, maintain Approved Distribution List updated; as well as, their supporting documentation; lead effort to improve the system in the region.
3. Perform Quality audits to the operation and facilities of MDD Distributors across LATAM Region according to the Audit Program.
4. Provide audit reports by written of all Quality Audits conducted and provide follow-up to the audits, as needed
5. Analyze results obtained during the audits, build and keep an updated dashboard for Suppliers, Distributors, Servicios Integrales and In Plants
6. Lead the Distributor Program in Mexico, and if needed in the Region
7. Implement the Quality Management System (QMS) in all sites with a business model of “In Plants” or “Servicios Integrales”, ensuring the operations meet the Good Warehousing and Distribution Practices according to the Local Regulation
8. Ensure full implementation of the QMS in the sites and/or areas assigned to his/her responsibility
9. Provide training on Quality Systems and/or any related topic, as needed.
10. Report to the Quality and Compliance Manager, as well as, CLS Manager any activity that may present risks within the J&J operation or within an In Plant or Servicios Integrales facility
11. Ensure products are stored and handled according to the regulatory requirements, and J&J policies dealing with Quality, Health & Safety and Environmental in all In Plant and Servicios Integrales locations
12. Has authority to stop any process that is a high potential risk for quality product or regulatory aspect.
13. Receive any Inspection / Visit from the Heath Authority in an In Plant
14. Became a back-up in any other System such as Product Complaints, Compliance Alert, CoAs, Training, Change Control, CAPAs, etc; as needed.
15. Support any other Quality System implementation, as needed.
Qualifications
Education
Experience
- Bachelor of Science Graduated on: Chemistry, Biochemistry, Biology, Engineer or any other similar Bs in the medical-biological field
- English: 80%
- Full command in communication, writing and oral.
- At least 3 to 5 years of experience implementing Quality Systems
- Experience conducting Quality Audits
- Experience in CAPAs, Change Control, Validation, Cold chain, training, data analysis, project administration and SOPs preparation.
- Knowledge in Local Regulation, such as, NOM 240 and NOM 241.
- Full command in Microsoft Office (Excel, Word, PP).
- Desirable: Experience in Medical Devices, Post Market Surveillance (Technovigilance) and Complaint Handling.
Primary Location:Latin America-Mexico
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Quality (Eng)